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Garner Efficiencies in Regulatory and Reimbursement Processes in a COVID Era
The Original Forum for Life Sciences Providing Exclusive Access to FDA/CMS Regulators to Examine Shifting Regulatory and Reimbursement Policy
Who Should Attend
You will benefit from attending this event if you are from a bio/pharma or medical device/diagnostic company with responsibilities or involvement in the following areas:
Public Policy & Strategy
Payment and Healthcare
This conference will also benefit consultants and software providers that provide services to life science companies.
What to Expect
Garner the Latest Regulatory Updates
- Discuss FDA and CMS perspectives on the impact of the pandemic on regulatory approval and reimbursement processes — Which efficiency and process shifts are here to stay?
- Explore trends in decentralization and digital enablement of clinical trials — Identify next steps to achieve diversity in clinical trials
- Advance cross-center (CBER/CDER) approaches to incorporate patient engagement in regulatory decision-making
- Consider next steps to realize the full potential of RWE in drug development
Examine the Latest Updates to Reimbursement Policy
- Understand the current state of value-based reimbursement models in the midst of the pandemic and the impact on the future of value-based care
- Examine reimbursement status of new technologies and advanced therapies under new payment models
- Review updates on Medicare coverage and access — Discuss CMS advancements in expanding telehealth benefits and the focus on improving plan incentives to align with what patients value
Political Landscape Shifts and Market Trends that Impact Drug Development
- Assess the impact of the 2020 election on drug pricing reform
- 21st Century Cures Act 2.0 — Consider the impact on drug development and patient access
- Address challenges and opportunities in cell and gene therapy development
- Evaluate the future for the drug development supply chain — What are the potential capabilities and pros/cons of domestic manufacturing?
Connect and Network with Key Decision-Makers at the 2021 FDA/CMS Summit
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